DEPLOYDatabase

Incident · Recall

Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding

Intuitive recalled da Vinci X/Xi SureForm 45 staplers (REF 480445 / 480545 / 480460) because tissue pushout during stapler firing could cause critical bleeding. Distinct failure mode and Z-number from the same-era SureForm staple-fragment recall already recorded. Source: FDA Class 2 device recall Z-0999-2022, openFDA enforcement / accessdata.fda.gov.

Occurred 2022-03-17 · Intuitive Surgical · Investigated by FDA

How to read this record

Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding

Machine-readable surfaces

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=192324

Common questions

What happened in Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
Intuitive recalled da Vinci X/Xi SureForm 45 staplers (REF 480445 / 480545 / 480460) because tissue pushout during stapler firing could cause critical bleeding. Distinct failure mode and Z-number from the same-era SureForm staple-fragment recall already recorded. Source: FDA Class 2 device recall Z-0999-2022, openFDA enforcement / accessdata.fda.gov.
When did this incident occur?
The incident is recorded as occurring on March 17, 2022 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
Who was involved in Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
Has anyone responded to Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-09

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding.

Deploy Watch

Track this incident.

We notify you when the regulator updates the record, the remedy status changes, or a related incident surfaces.

Canonical ID 955a6513-2110-43ba-98b4-92cfbee12f98